Nulojix
Nulojix (belatacept) is an immunosuppressant that works to prevent your body from rejecting a transplanted organ. This monthly infusion through the vein is FDA approved for adults who've had a kidney transplant only. Nulojix (belatacept) is typically given by a trained healthcare professional in a healthcare setting. Side effects can include anemia; swelling in the arms, legs, or feet; and changes in blood pressure. Nulojix (belatacept) is typically taken with other transplant medications to prevent organ rejection.
What is Nulojix (belatacept)?
What is Nulojix (belatacept) used for?
- Prevention of organ rejection in adults who've had a kidney transplant
How Nulojix (belatacept) works
Nulojix (belatacept) is a type of immunosuppressant called a selective T-cell costimulation blocker. It attaches to two spots on the surface of certain immune cells in your body. The medication stops T-cells from becoming active, recognizing your transplanted kidney as foreign, and attacking it. This helps prevent organ rejection.
Drug facts
| Common Brands | Nulojix |
|---|---|
| Drug Class | Immunosuppressant |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Nulojix (belatacept)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Anemia (45%)
- Diarrhea (39%)
- Constipation (33%)
- Urinary tract infection (37%)
- Swelling in the arms, legs, or feet (34%)
- High blood pressure (32%)
- Fever (28%)
- Cough (24%)
- Vomiting (22%)
- Headache (21%)
Less Common Side Effects
- Belly pain
- Joint pain
- Pain or discomfort while urinating
- Trouble sleeping
- Anxiety
- Flu-like symptoms
- Upper respiratory infection
- Other infection
- Low blood pressure
- Changes in electrolyte levels
- Higher cholesterol levels
- Low white blood cell count
Nulojix (belatacept) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Post-transplant lymphoproliferative disorder (PTLD): fever; night sweats; not feeling well; unplanned weight loss; lower appetite; swollen lymph node in the neck, armpit, or groin; unusual changes in mood or behavior; confusion; problems thinking; movement problems
- Infection: fever, chills, muscle aches, change in appetite, vomiting, pain while urinating, weight loss, skin rash
The following Nulojix (belatacept) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
Abdominal or stomach pain
agitation
black, tarry stools
bladder pain
bloating or swelling of the face, arms, hands, lower legs, or feet
bloody or cloudy urine
blurred vision
bone pain
burning while urinating
chills
coma
confusion
convulsions
cough or hoarseness
decreased frequency or amount of urine
decreased urine output
difficult or labored breathing
difficult, burning, or painful urination
dizziness
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
drowsiness
fainting
fast or irregular heartbeat
frequent urge to urinate
headache
hostility
inability to move the arms and legs
increased blood pressure
increased thirst
irritability
itching in other skin areas
lethargy
loss of appetite
loss of bladder control
lower back or side pain
mood or mental changes
muscle pain or cramps
muscle spasms (tetany) or twitching
nausea or vomiting
nervousness
numbness or tingling in the hands, feet, or lips
pale skin
pounding in the ears
rapid weight gain
scaling
shortness of breath
slow or fast heartbeat
sores, ulcers, or white spots on the lips or in the mouth
stupor
sudden decrease in the amount of urine
sudden numbness and weakness in the arms and legs
sweating
swelling of the face, ankles, or hands
swollen glands
tightness in the chest
trembling
troubled breathing
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
unusual weight gain or loss
weakness or heaviness of the legs
Less common
Back pain
coughing or spitting up blood
drowsiness
joint pain, stiffness, or swelling
loss of appetite
night sweats
persistent non-healing sore
pink growth reddish patch or irritated area
shiny bump
sudden high fever or low-grade fever for months
swelling of the feet or lower legs
white, yellow, or waxy scar-like area
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Abdominal or stomach cramps
blemishes on the skin
body aches or pain
collection of blood under the skin
cough producing mucus
deep, dark purple bruise
difficulty having a bowel movement (stool)
difficulty with moving
ear congestion
flushed, dry skin
fruit-like breath odor
hair loss or thinning of the hair
increased hunger
increased sweating
increased urination
itching, pain, redness, or swelling
loss of consciousness
loss of voice
muscle cramps in the hands, arms, feet, legs, or face
muscle or bone pain
muscle pain or stiffness
numbness and tingling around the mouth, fingertips, or feet
pain in the joints
shakiness in the legs, arms, hands, or feet
shortness of breath
swelling or inflammation of the mouth
tightness in the chest
trouble sleeping
unable to sleep
unexplained weight loss
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Nulojix (belatacept)
Pros
- Given once a month (after a few starter doses)
- Less likely to cause kidney damage than certain other transplant medications (e.g., calcineurin inhibitors)
Cons
- Only used for people who've been exposed to the Epstein-Barr virus (EBV)
- Not approved for children 17 years and younger who've had a transplant
- Not approved for people with other organ transplants; only for people who've had a kidney transplant
Pharmacist tips for Nulojix (belatacept)
- Before you start Nulojix (belatacept), let your transplant specialist know if you typically need to get poked more than once when you get any blood tests done. This could mean that it's tricky to find a vein that can be used easily for blood draws and infusions. It might make it more difficult for you to receive the Nulojix (belatacept) infusion through the vein.
- Follow the dosing schedule that your transplant specialist gives you for your Nulojix (belatacept) infusions. Be sure to put your appointments in your calendar and set reminders for them. This will help you stay on track with your treatment.
- Call your transplant team if you can't make it to your appointment for your Nulojix (belatacept) infusion or if you forget to go. At the beginning of treatment, your transplant specialist might need to adjust your dosing schedule. And once you can get your infusions monthly, it's okay if you get your infusion within 3 days (before or after) of your originally scheduled date. But you still need to reschedule.
- Make sure to continue taking your other medications that help prevent organ rejection as instructed by your transplant specialist. You should be taking Nulojix (belatacept) together with steroids like prednisone, another transplant medication (usually mycophenolate (CellCept)), or both.
- Check your blood pressure at home often because Nulojix (belatacept) can cause changes to your blood pressure (can go up or down). Share the numbers with your transplant specialist and your primary care provider. Your prescriber might need to adjust the dose any blood pressure medications you might be taking.
- Limit your time out in direct sunlight, wear protective clothing, and use sunblock when you're outside. Taking immunosuppressants like Nulojix (belatacept) can put you at risk for skin cancer. These are things you can do to help lower your risk.
- Before you get any vaccines, tell the pharmacist or healthcare professional that you're taking Nulojix (belatacept). They can make sure it's safe for you to get the vaccine. This medication can change the way your immune system responds to vaccines. Avoid live vaccines, like the nasal spray flu vaccine, while you're taking this medication because you're at higher risk of getting sick from the the vaccine itself.
Risks and warnings for Nulojix (belatacept)
Nulojix (belatacept) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Must be under the care of an experienced transplant specialist
An experienced transplant specialist will manage your treatment with Nulojix (belatacept). This is important because the medication weakens the immune system and puts you at risk for many serious complications. The care team will have the appropriate resources available to make sure your treatment is going well and is safe for you.
Post-transplant lymphoproliferative disorder (PTLD)
- Risk factors: People who've never been exposed to Epstein-Barr virus | Have a cytomegalovirus (CMV) infection | T cell-depleting therapy | Taking higher-than-recommended or frequent doses of Nulojix (belatacept) | Taking higher-than-recommended doses of other immunosuppressants
People treated with Nulojix (belatacept) have a greater risk for developing post-transplant lymphoproliferative disorder (PTLD) than those treated with cyclosporine. PTLD is a serious condition that can happen after your transplantation. It happens when your white blood cells multiply abnormally, which can potentially lead to lymphoma (a type of blood cancer).
The risk for PTLD is even higher for people who don't have antibodies to Epstein-Barr virus (EBV) and for people who have a cytomegalovirus (CMV) infection. You're also at higher risk if you're receiving T cell-depleting therapies in the hospital to treat rejection.
Contact your transplant specialist if you have fever, night sweats, unplanned weight loss, lower appetite, or changes in vision. Also let them know if you feel a swollen lymph node in the neck, armpit, or groin. Call your transplant specialist right away if you or your loved ones notice unusual changes in mood or behavior, confusion, or problems thinking. These all can be signs of PTLD.
Risk for cancer, including skin cancer
People who take immunosuppressants like Nulojix (belatacept) are at higher risk of developing cancers, such as skin cancer. This is because these medications lower the ability of your body to fight cells that become abnormal.
Lower your risk for skin cancer by limiting your exposure to sunlight and ultraviolet (UV) light. Also wear protective clothing and use sunblock when you're outside.
Serious infections
- Risk factors: Taking other immunosuppressants | Taking higher-than-recommended and more frequent doses of Nulojix (belatacept)
Nulojix (belatacept) weakens your immune system. It can put you at risk of developing serious or life-threatening bacterial, fungal, and viral infections. During treatment, certain infections that you've had in the past, such as tuberculosis (TB), can come back. And sometimes, opportunistic infections (those that usually only cause problems when the immune system is weak) can develop and potentially lead to serious complications.
Before you start Nulojix (belatacept), your transplant specialist will examine you to check for any infections. Let them know if you have a history of frequent infections, infections that keep coming back, or any long-term infections. Your transplant specialist will talk with you about taking additional medications to protect against infection.
In general, avoid getting sick by trying to stay away from people who are ill. Wash your hands often. Call your transplant specialist right away if you develop symptoms of an infection, such as fever, chills, muscle aches, change in appetite, weight loss, vomiting, or pain while urinating.
Not recommended for people who've had a liver transplant
Nulojix (belatacept) isn't recommended and isn't FDA approved for people who've had a liver transplant. In a clinical study of people who had a liver transplant, those who received Nulojix (belatacept) had a higher risk for graft loss (losing their transplant) and death than those who received tacrolimus (Prograf). Your transplant specialist will discuss with you about safer transplant medications if you had a liver transplant.
Change in immune response to vaccines
Transplant medications like Nulojix (belatacept) can change the way your immune system responds to vaccines. Some vaccines might not work as well to protect you from infection. Avoid getting any live vaccines while you're taking this medication because your risk of getting sick from the vaccine itself is higher.
Always tell your healthcare professional or pharmacist that you're taking an immunosuppressant like Nulojix (belatacept) before you get vaccinated. They can let you know whether the shot you'd like to receive safe for you.
Nulojix (belatacept) dosage
Typical dosage for Nulojix (belatacept)
Nulojix (belatacept) is an intravenous (IV) infusion that's given through your vein. It's administered by a trained healthcare professional.
The dose depends on your body weight. In general, you'll follow a dosing schedule that your transplant specialist sets for you. The dosing schedule might look like the following.
Initial phase
- The typical dose is 10 mg/kg of body weight given IV:
- On day 1 (the day of your transplant)
- On day 5
- At the end of week 2 after transplantation
- At the end of week 4 after transplantation
- At the end of week 8 after transplantation
- At the end of week 12 after transplantation
Maintenance phase
- The typical dose is 5 mg/kg of body weight given IV:
- At the end of week 16 after transplantation
- Then, once every 4 weeks
Interactions between Nulojix (belatacept) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adenovirus Vaccine
- Antithymocyte Globulin Equine
- Antithymocyte Globulin Rabbit
- Bacillus of Calmette and Guerin Vaccine, Live
- Cholera Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Vaccine
- Tofacitinib
- Typhoid Vaccine, Live
- Varicella Virus Vaccine, Live
- Yellow Fever Vaccine
- Zoster Vaccine, Live
Nulojix (belatacept) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Nulojix (belatacept) will not be safe for you to take.
- People who test negative for Epstein-Barr virus (EBV), meaning that they don't have antibodies to the virus in the body
- People with an unknown EBV status
